Directly Observed Antiretroviral Therapy Among Active Drug Users

HIV/AIDS Clinical Trial

Official title:

Directly Observed Antiretroviral Therapy Among Active Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367172
• Other study ID #: 0003011701
• Secondary ID: R01DA013805
• Status: Completed
• Phase: N/A
• Start date: June 2001
• Est. completion date: December 2006

Study information

• Verified date: August 2009
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this randomized, controlled trial is to compare the effectiveness of a community-based program of providing supervised antiretroviral therapy to HIV-positive drug users, compared to having the patients take the medicines on their own.

Description:

Highly active antiretroviral therapy (HAART) has dramatically reduced morbidity and mortality from HIV disease, but these benefits have not been conferred equally among all patient populations. Injection drug users (IDUs) have shown particularly less favorable outcomes, with HIV progression remaining at high levels, and IDU remains a significant risk behavior for the spread of HIV worldwide, with explosive epidemics in Eastern Europe, Russia, and Southeast Asia. It is therefore essential to develop and test strategies of HIV treatment that optimize outcomes for this population, in order to reduce morbidity and mortality and to curb secondary transmission.

Directly observed therapy (DOT) for tuberculosis has resulted in impressive improvements in adherence and clinical response and marked reductions in the development of resistance. The time-limited treatment of tuberculosis, the inherently different transmission patterns of tuberculosis and HIV, and the complexity of antiretroviral therapy have raised concerns about translating the DOT model to HIV. Successful, but non-comparative demonstration programs of directly administered antiretroviral therapy (DAART) have been implemented in methadone maintenance programs, community-based settings, skilled nursing facilities, and in prisons. None of these, however, have targeted active drug users or used a prospective, randomized controlled trial (RCT) design to rigorously determine the efficacy of DAART as an intervention to improve HIV outcomes among active drug users. One RCT of DAART recently failed to demonstrate an impact on virological outcomes among low-income HIV+ patients, but these results are unlikely to be applicable to IDUs or other populations with demonstrated problematic adherence.

We therefore conducted the first randomized controlled trial to address this question, consisting of six months of DAART versus self-administered therapy (SAT) among active drug users in a community setting. The objective was to determine the potential efficacy of a six-month DAART program on HIV infection, using surrogate markers of HIV- RNA levels and CD4+ T lymphocyte counts.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. being HIV seropositive;

2. being eligible for and/or being prescribed HAART

3. living within the city of New Haven

4. actively using heroin and/or cocaine in the previous six months

5. receiving no more than a twice-daily regimen

Exclusion Criteria:

Not meeting inclusion criteria

Related Conditions & MeSH terms

• HIV/AIDS
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• Directly Administered Antiretroviral Therapy

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Altice FL, Mezger JA, Hodges J, Bruce RD, Marinovich A, Walton M, Springer SA, Friedland GH. Developing a directly administered antiretroviral therapy intervention for HIV-infected drug users: implications for program replication. Clin Infect Dis. 2004 Jun 1;38 Suppl 5:S376-87. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virological Success, defined as greater than 1 Log HIV-1 Copies/mL reduction or Viral Load Less than 400 copies/mL at the end of six months on the intervention.
Secondary	Mean change in HIV-1 viral load from baseline to six months at the end of the intervention.
Secondary	Virological Success at six months following the termination of the intervention.
Secondary	3-Day Recall measures of adherence at the end of six months on the intervention.
Secondary	Mean change in HIV-1 viral load from baseline six months following the termination of the intervention.
Secondary	Mean change in CD4+ T cells from baseline to the end of six months on the intervention.